The government is set to expand the basket of over the-counter (OTC) medicines by adding around 100 new drugs which are currently sold on prescription in an attempt to make such medication more accessible and reduce irrational application or misuse of high risk drugs, especially antibiotics.

“We are planning to introduce a separate schedule for OTC drugs. This will include commonly used drugs which are of low risk and have been in use for a long term with proven efficacy. Besides, we are also considering such medicines available over the counter in other developed international markets,“ drugs controller general of India (DCGI) G N Singh told TOI.

Drugs likely to get off prescription will initially include those commonly used for cold, cough and analgesics such as paracetamol and ibuprofen. Many of these medicines are already sold illegally as OTC. In the process, in the absence of clear regulation, many high-end antibiotics and critical medicines also get pushed by chemists without prescriptions.

This leads to concerns about misuse of medicines and anti-microbial resistance. “ Apart from making commonly used drugs accessible, our main aim is to tackle the problem of antibiotic resistance. By making the rule book simple, we want to ensure that everyone abides by it,“ Singh said.

At a later stage, the regulator may also consider placing some medicines for diabetes and hypertension considered low-risk and frequently prescribed under the OTC category , an official said.

While the proposal to make commonly used medicines more accessible has been in the pipeline, the drug regulator has now set up a committee to draw a legal regulatory framework which will have a separate schedule for OTC under the drug and cosmetics rules. It could be mandatory for companies to label such drugs “OTC“, making it easier for consumers to distinguish them. The decision was taken in a high-level regulatory meeting held earlier this week.

Currently, “OTC' has no legal recognition in India and all drugs not included in the list of `prescription-only' drugs are considered so and legally allowed to be sold over the counter. The move also assumes significance as India's OTC drug market, currently pegged at around $4 billion, is growing rapidly with many pharmaceutical companies launching products in categories such as mother-and-child care, weight management, dietary supplements and cardiac care.

Once the proposal is approved by the health ministry, consumers will be able to buy common medicines from the chemists or even from a retail store without going to a doctor for a prescription. However, companies manufacturing such medicines would still require an approved license from the regulator and essential drugs will continue to fall under price control, Singh said. The move also assumes significance as pharmaceutical companies are launching more OTC products in categories such as mother and-child care, weight management, dietary supplements and even cardiac care. These products involve large margins, and experts say these segments are expected to witness rapid growth because of lifestyle diseases and consumers turning health conscious.

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